Job Title: Safety Regulatory Reporting and Global Complaints Analyst

Location: Plymouth, MN 55442 (Hybrid)

Duration: 6 Months Contract

Details:

Description:

Position Summary:

The temporary position is responsible for managing device complaints and adverse events globally. This may include: complaint initial triage, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable department, providing updates to reports, reviewing for closure/reopening as needed, and assuring timely processing of complaints.

Essential Duties & Responsibilities:

• Responsible for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally.

• Responsible for creating and submitting regulatory reports to the FDA.

• Works independently and is accountable for completing task as assigned.

• Works well in a team to accomplish team goals.

Knowledge & Skills:

• Experience with or knowledge of medical terminology and how medical/pharmaceutical products are typically used in a clinical setting.

• Basic computer and software skills.

• Must be able to communicate effectively with internal and external customers.

• Demonstrate ability to collect, analyze and interpret complaint and adverse event information

Experience:

· 2 years’ experience in a health care environment, and/or within a quality/compliance/regulatory organisation

Required Skills:

· Must be able to communicate in English.

· Bachelor’s Degree in Engineering, Medical Sciences, or other related scientific field required.

· 2 years’ experience in a health care environment, and/or within a quality/compliance/regulatory organisation.

· US FDA Medical Device Reporting and experience with Trackwise Digital preferred.

· Managing device complaints and adverse events globally

Education:

· Bachelor’s Degree in Engineering, Medical Sciences, or other related scientific field required

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

Recruiter Details:
Name: Mirza Belal Beg
Email: Teamzebra@ustechsolutions.com
Internal Reference Id: 24-10118

Job Types: Full-time, Contract

Pay: $35.00 per hour

Schedule:

• 8 hour shift

Ability to Relocate:

• Plymouth, MN: Relocate before starting work (Required)

Work Location: In person